A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
Primary Purpose
Unilateral Primary Osteoarthritis, Unspecified Hip
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Monocryl closure
Vicryl and Staple closure
Tegaderm dressing
Gauze dressing
Sponsored by

About this trial
This is an interventional treatment trial for Unilateral Primary Osteoarthritis, Unspecified Hip focused on measuring Suture, Skin staples, Vicryl, Monocryl
Eligibility Criteria
Inclusion Criteria:
- 18 - 100 years old
- Undergoing total hip replacement
Exclusion Criteria:
- Previous scar over newly planned incision
- Alcoholism
- Mentally unfit to complete questionnaire
- Connective tissue disease and/or psoriasis/eczema/dermatitis
- Previous joint infection at surgical site
- Any use of immunosuppressive medications or disease modifying agents
- Medical contra-indication to surgery
- Pregnancy
- Lack of permanent home address
- Drug Abuse
- Allergy to Skin Adhesive
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Monocryl closure
Vicryl and staple closure
Arm Description
The skin incision is closed with monocryl dissolvable sutures and a topical adhesive (glue) called Dermabond and covered with a Tegaderm dressing. Intervention: Monocryl closure, Tegaderm dressing
The skin incision is closed with vicryl and staples and covered with a gauze dressing. Intervention: Vicryl and Staple closure, Gauze dressing
Outcomes
Primary Outcome Measures
Patient Observer Scar Assessment Scale for overall patient satisfaction rates.
Questionnaire
Secondary Outcome Measures
Wound complications
Analysis - number of participants with wound complications
Drainage rates
Analysis - number of participants with wound drainage
Need for post-operative antibiotics
Analysis - number of participants with need for post-operative antibiotics
Patient pain score
Questionnaire
Full Information
NCT ID
NCT02519829
First Posted
May 28, 2015
Last Updated
August 6, 2015
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02519829
Brief Title
A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
Official Title
A Randomized Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients undergoing primary hip arthroplasty will be randomized to receive either monocryl closure of fascial and dermal layers with dermabond and tegaderm covering versus standard vicryl closure of fascia layer and staple closure for skin. Short term wound complications, pain and patient and surgeon-rated cosmetic scar appearance will be measured. The investigators will also measure operating room time and costs associated with dressing changes and wound-related procedures (e.g. staple removal).
Detailed Description
Wound closure has always been based on surgeon preference and type of closure. Skin closure is considered the most important part of the surgical procedure by some since it is often the only visible evidence of the surgical procedure. In fact, conclusions about the success of the surgery are often based on the appearance of the wound.
There have been a few studies in a variety of surgical journals that have looked at the two pertinent methods of closure with the majority coming from obstetrical journals comparing caesarian section closure with staples versus a subcuticular monocryl suture. For the most part, although patient satisfaction is quite high initially for a subcuticular closure, at long term follow-up patient satisfaction scores are quite similar.
One study published in the Journal of Bone and Joint Surgery recommended that staple closure was more beneficial for skin closure than monocryl sutures for total hip and knee arthroplasty. Their recommendations were based on an overall shorter operative time when using staple closure compared to monocryl sutures. They also found that final patient satisfaction and complication rates were relatively similar 3 months postoperatively. This group published an earlier paper as well describing the use of glue for closure and did report an decrease in overall drainage rates when they analyzed their data for subcuticular sutures as opposed to staples.
A more recent study evaluated wound appearance at 3 months using a surgeon -rated visual analogue scale to compared the use of adhesive tapes versus staples for skin closure following total hip arthroplasty. Again, no significant difference in patient satisfaction scores were reported.
To date, there is a paucity of well-powered studies to compare outcomes in patients whose wounds are closed using the usual staple methods compared to a monocryl suture method. In addition, outcomes have focused on surgeon-ratings and not patient ratings. The proposal for this study is to compare overall patient and surgeon-rated cosmetic scar appearance and complications following total hip replacement with skin closure for using monocryl suture versus staples. This study would use a more recent, validated assessment tool than the VAS scale. The assessment is called the Patient Observer Scar Assessment Scale (POSAS ) and it incorporates six essential features about the wound such as colour, malleability, etc. The form is split so that the surgeon rating carries the same weight in the final score as the patient assessment of their own scar. This scale gives a nice balance for determining overall satisfaction and wound healing combining surgeon and patient scores.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Primary Osteoarthritis, Unspecified Hip
Keywords
Suture, Skin staples, Vicryl, Monocryl
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monocryl closure
Arm Type
Active Comparator
Arm Description
The skin incision is closed with monocryl dissolvable sutures and a topical adhesive (glue) called Dermabond and covered with a Tegaderm dressing.
Intervention: Monocryl closure, Tegaderm dressing
Arm Title
Vicryl and staple closure
Arm Type
Active Comparator
Arm Description
The skin incision is closed with vicryl and staples and covered with a gauze dressing.
Intervention: Vicryl and Staple closure, Gauze dressing
Intervention Type
Procedure
Intervention Name(s)
Monocryl closure
Intervention Description
Total Hip Arthroplasty with monocryl closure of wound
Intervention Type
Procedure
Intervention Name(s)
Vicryl and Staple closure
Intervention Description
Total Hip Arthroplasty with vicryl and staple closure of wound
Intervention Type
Procedure
Intervention Name(s)
Tegaderm dressing
Intervention Description
Total Hip Arthroplasty with monocryl closure of wound and tegaderm dressing
Intervention Type
Procedure
Intervention Name(s)
Gauze dressing
Intervention Description
Total Hip Arthroplasty with vicryl and staple closure of wound and gauze dressing
Primary Outcome Measure Information:
Title
Patient Observer Scar Assessment Scale for overall patient satisfaction rates.
Description
Questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Wound complications
Description
Analysis - number of participants with wound complications
Time Frame
2 week, 6 week, 3 month post-operatively
Title
Drainage rates
Description
Analysis - number of participants with wound drainage
Time Frame
2 week, 6 week, 3 month post-operatively
Title
Need for post-operative antibiotics
Description
Analysis - number of participants with need for post-operative antibiotics
Time Frame
2 week, 6 week, 3 month post-operatively
Title
Patient pain score
Description
Questionnaire
Time Frame
2 week, 6 week, 3 month post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 - 100 years old
Undergoing total hip replacement
Exclusion Criteria:
Previous scar over newly planned incision
Alcoholism
Mentally unfit to complete questionnaire
Connective tissue disease and/or psoriasis/eczema/dermatitis
Previous joint infection at surgical site
Any use of immunosuppressive medications or disease modifying agents
Medical contra-indication to surgery
Pregnancy
Lack of permanent home address
Drug Abuse
Allergy to Skin Adhesive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James L Howard, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial Comparing Monocryl and Dermabond Closure Versus Staple Closure in Total Hip Arthroplasty
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